BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 21834859 · Received April 14, 2025

    Report

    Report Number
    3017374019-2025-00013
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    November 19, 2023
    Report Date
    April 14, 2025
    Manufacturer
    AVERTIX MEDICAL INC
    Product Code
    QBI
    PMA / PMN Number
    P150009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WENT TO THE ER WITH A SEE DR. LOW BATTERY ALERT FROM (B)(6). DEVICE WAS INTERROGATED ON (B)(6) 2023 AND CONFIRMED THE IMD HAD A LOW BATTERY ALERT. IMD WAS EXPLANTED AND REPLACED WITH IMD (B)(6) ON (B)(6) 2023. IMD (B)(6) WAS SENT TO DECONTAMINATION AND RETURNED TO AVERTIX FOR INVESTIGATION. THIS WS ONE OF 25 DEVICES IMPACTED BY A BATTERY QC ISSUE. THIS MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII. AVERTIX PERFORMED A VOLUNTARY RECALL/CORRECTION A COUPLE YEARS AGO FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022815 THE GUARDIAN SYSTEM GUARDIAN QBI AVERTIX MEDICAL INC AMSG3-E 021721V0210150000047

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention